BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2870972 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02353
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    May 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012, DUE TO CELLULITIS AND SWELLING AROUND THE IMPLANT SITE. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH INTRAVENOUS UNASYN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012, AND WAS PRESCRIBED AUGMENTIN. THE INFECTION WAS RESOLVED, AND NO FURTHER REPORTS OF INFECTION HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT, (B)(4) 2012. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Required Intervention